The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Prog Iii Calibrator Set.
| Device ID | K153417 |
| 510k Number | K153417 |
| Device Name: | ST AIA-PACK PROG III Calibrator Set |
| Classification | Calibrator, Secondary |
| Applicant | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Robert L. Wick |
| Correspondent | Robert L. Wick TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2015-12-18 |
| Summary: | summary |